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New Drug Approvals Archive - April 2019

See also: New Indications and Dosage Forms for April 2019

April 2019

Asceniv (immune globulin intravenous, human – slra) Injection

Date of Approval: April 1, 2019
Company: ADMA Biologics, Inc.
Treatment for: Primary Immunodeficiency Syndrome

Asceniv (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI).

Dovato (dolutegravir and lamivudine) Tablets

Date of Approval: April 8, 2019
Company: ViiV Healthcare
Treatment for: HIV Infection

Dovato (dolutegravir and lamivudine) is a once-daily, single-tablet, two-drug regimen of the approved drugs dolutegravir (Tivicay) and lamivudine (Epivir) indicated for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either dolutegravir or lamivudine.

Evenity (romosozumab-aqqg) Injection

Date of Approval: April 9, 2019
Company: Amgen Inc.
Treatment for: Osteoporosis

Evenity (romosozumab) is an anti-sclerostin monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Balversa (erdafitinib) Tablets

Date of Approval: April 12, 2019
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Urothelial Carcinoma

Balversa (erdafitinib) is a once-daily, oral, pan-fibroblast growth factor receptor for the treatment of patients with locally advanced or metastatic urothelial cancer.

Plenity (cellulose and citric acid) Capsules

Date of Approval: April 12, 2019
Company: Gelesis
Treatment for: Obesity

Plenity (cellulose and citric acid) is an oral, non-systemic, superabsorbent hydrogel used in conjunction with diet and exercise to aid weight management in adults who are overweight or obese. It works by inducing a feeling of fullness so that patients eat less and lose weight.

Skyrizi (risankizumab-rzaa) Injection

Date of Approval: April 23, 2019
Company: AbbVie Inc.
Treatment for: Plaque Psoriasis

Skyrizi (risankizumab-rzaa) is an interleukin-23 (IL-23) inhibitor for the treatment of plaque psoriasis.

Duobrii (halobetasol propionate and tazarotene) Lotion

Date of Approval: April 25, 2019
Company: Ortho Dermatologics
Treatment for: Plaque Psoriasis

Duobrii (halobetasol propionate and tazarotene) is a corticosteroid and retinoid combination indicated for the topical treatment of plaque psoriasis.

Eticovo (etanercept-ykro) Injection

Date of Approval: April 25, 2019
Company: Samsung Bioepis Co., Ltd.

Eticovo (etanercept-ykro) is a tumor necrosis factor (TNF) blocker biosimilar to Enbrel indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

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